(119 days)
The microMESAM® Basic-Set is used for recording the patient's respiratory nasal pressure during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
The MicroMESAM® Basic-Set consists of a reusable microMESAM® recorder, disposable nasal pressure cannula and patient's instruction manuals, microMESAM® installation CD, system instruction manual for specialist medical personnel, batteries, reusable belt for attaching the microMESAM® recorder, USB cable, carrying bag, and Luer-lock caps. The microMESAM® recorder is a single channel battery-powered respiratory pressure sensor system and provides recordings of respiratory pressure during sleep. The physician prescribed device will help to recognise sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may actually perform the recording at home by himself. The microMESAM® recorder must be fastened with the reusable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal pressure cannula. The disposable plastic nasal pressure cannula is connected to the microMESAM® recorder and fixed at the patient's nose. After recording, the microMESAM® recorder must be returned to the physician. With the microMESAM® software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analysed data.
Here's a breakdown of the acceptance criteria and study information for the microMESAM® Basic-Set, based on the provided text:
Acceptance Criteria and Study Information for microMESAM® Basic-Set
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a table format with numerical targets. However, the performance data section implies the criteria for substantial equivalence were met by demonstrating high correlation with the gold standard (PSG) and effective detection of Sleep Disordered Breathing (SDB). I've interpreted the key correlating factors and the derived sensitivities/specificities as the performance outcomes that demonstrate meeting implicit acceptance criteria for a screening device.
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|
| Signal Quality (Flow-time curves correlation with pneumotachograph) | Corresponded in 95% of respiratory events, with less than 4±2% difference in area under the curves. |
| Correlation of Apneas (with PSG) | r = 0.99 |
| Correlation of Hypopneas (with PSG) | r = 0.81 |
| Correlation of AHI (with PSG) | r = 0.98 |
| Mean difference in AHI (microMESAM vs PSG) | 3.8 |
| 1.96 Intervall of AHI difference (microMESAM vs PSG) | +11.1 to -3.5/h |
| Sensitivity for SDB (at AHI of 5) | 97.3% |
| Specificity for SDB (at AHI of 5) | 46% |
| Sensitivity for SDB (at AHI of 10) | 100% |
| Specificity for SDB (at AHI of 10) | 87.5% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 50 patients
- Data Provenance: The document does not explicitly state the country of origin, but the submitting company is based in Germany. It is a prospective study, as it involved "50 patients suspected of having obstructive sleep apnoea" where microMESAM-generated automated analysis was compared with simultaneously collected PSG data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The study compared "MicroMESAM-generated automated analysis with manually scored results of simultaneously collected PSG data." This indicates that human experts were involved in scoring the PSG data, which served as the ground truth.
- Number of Experts: Not specified.
- Qualifications of Experts: The document does not explicitly state the qualifications of the experts who manually scored the PSG data. However, the phrasing "manually scored results of simultaneously collected PSG data" implies qualified sleep specialists or technicians trained in PSG scoring, as PSG is the "gold standard in the diagnosis of sleep disordered breathing (SDB)."
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (such as 2+1 or 3+1). It states that the microMESAM's automated analysis was compared to "manually scored results" of PSG. This suggests a direct comparison to a single expert's or a consensus's manual scoring of the PSG, but the specific process isn't detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not explicitly described. The study compared the device's automated analysis to manually scored PSG data, not to human readers with vs. without AI assistance.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance study describes the standalone performance of the microMESAM® Basic-Set's automated analysis. It explicitly states comparing "MicroMESAM-generated automated analysis" with the ground truth (manually scored PSG data). The device automates the analysis of apnoeas, hypopnoeas, flow limitations, and snoring.
7. The Type of Ground Truth Used
The primary ground truth used was expert consensus / manual scoring of Polysomnography (PSG) data. PSG is referred to as the "gold standard in the diagnosis of sleep disordered breathing (SDB)." Additionally, there was an initial comparison of signal quality where "pneumotachograph-generated curves" served as a ground truth for microMESAM's flow-time curves.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The study described focuses on the validation of the device, implying that the algorithm and its analysis capabilities were already developed.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not explicitly mentioned, the method for establishing its ground truth is also not described in this document.
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1.2 510(k) SUMMARY of Safety & Effectiveness
| Submitter: | MAP Medizin-Technologie GmbHFraunhoferstrasse 1682152 MartinsriedGERMANY |
|---|---|
| Contact Person: | Torsten SchlichtholzDirector Quality Management and Regulatory Affairs |
| Phone No.: | +49 89 89518723 |
| Fax No.: | +49 89 89518820 |
| Date Prepared: | 1 March 2004 |
| Classification Reference: | 21 CFR 868.2375 |
| Product Code: | MNR – Ventilatory Effort Recorder |
| Device Class: | Class II |
| Common/Usual Name: | Ventilatory Effort Recorder |
| Proprietary Name: | microMESAM® Basic-Set |
| Predicate Device: | Aplab™ (K030379) |
| Distribution: | the product will be marketed in the USA byResMed Corp. |
Intended Use:
The microMESAM® Basic-Set is used for recording the patient's respiratory nasal pressure during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's test score.
Device Description:
The MicroMESAM® Basic-Set consists of:
| Number of | Type | Article No.: |
|---|---|---|
| 1 | Reusable microMESAM® recorder | 161800 |
| 50 | Disposable nasal pressure cannula and microMESAM®patient's instruction manuals | 1619 |
| 1 | microMESAM® installation CD | 167340 |
| 1 | System instruction manual for specialist medical personnel | 561761 |
| 2 | Batteries 1,5V Mignon | 85030 |
| 1 | Reusable belt for attaching the microMESAM® recorder | 629050 |
| 1 | USB cable | 629051 |
| 1 | Carrying bag | 530002 |
| 10 | Luer-lock caps | 626027 |
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The microMESAM® recorder is a single channel battery-powered respiratory pressure sensor system and provides recordings of respiratory pressure during sleep. The physician prescribed device will help to recognise sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may actually perform the recording at home by himself. The microMESAM® recorder must be fastened with the reusable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal pressure cannula. The disposable plastic nasal pressure cannula is connected to the microMESAM® recorder and fixed at the patient's nose. After recording, the microMESAM® recorder must be returned to the physician. With the microMESAM® software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analysed data.
Device Technological Characteristics and Comparison to Predicate Device:
The comparison table below, is provided, to demonstrate that the microMESAM® Basic-Set has no siqnificant differences from the predicate device that would adversely affect product safety and effectiveness.
| Comparison Parameter | Sector Medical Corp.ApLab™ | microMESAM® Basic-Set |
|---|---|---|
| Intended Use | ApLab™ is intended for usein recording respiratory nasalpressure during sleep. Thedevice is intended for use asa screening device todetermine the need forclinical diagnosis andevaluation bypolysomnography based onthe patient's score. | The microMESAM® Basic-Setis used for recordingpatient's respiratory nasalpressure during sleep. Thedevice is intended for use asa screening device todetermine the need forclinical diagnosis andevaluation bypolysomnography based onthe patient's test score. |
| Intended Environment | recording - at-homeanalysing - Sector Medical,physician's practice, sleepclinic | recording - at-homeanalysing – physician'spractice, sleep clinic |
| Population | 2 yrs or older | adults |
| Power Source recorder | 3-Volt Lithium battery | 2 x batteries: LR6 / Mignon /AA / 1.5V / at least 1.9 Ahor2 x NiMh accumulators:Mignon / AA / 1.2V / at least1.9 Ah |
| Number of channels | Single channel | Single channel |
| Method of connection to thePatient | Plastic tubing and cannulafor pressure sensing; elasticcloth material belt to supportunit. The device is to beattached to a patient's arm | Plastic tubing and cannulafor pressure sensing; elasticcloth material belt to supportunit. The device is to beattached to a patient's chest. |
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| Safety Characteristics | Use non-conducting,disposable, plastic cannula. | Use non-conducting,disposable, plastic cannula. |
|---|---|---|
| Re-use | Plastic cannula is single usedisposable. Remainingportions require cleaning | Plastic cannula is single usedisposable. Remainingportions require cleaning |
| Sensor Technology | Utilizes solid-state pressuresensor that converts pressurechanges to electrical signallevels | Utilizes solid-state pressuresensor that converts pressurechanges to electrical signallevels. |
| Analysing the recorded data | The recorded data may bedownloaded into theApLab™ software throughan USB 1.1 connectorplugged into the device.Afterwards the recordeddata are automaticallyanalysed and a report can begenerated. | The recorded data may bedownloaded into themicroMESAM® softwarethrough an USB 1.1connector plugged into thedevice. Afterwards therecorded data areautomatically analysed and areport can be generated. |
Performance data:
The microMESAM® Basic-Set complies with the following standards:
- IEC 60601-1 -
- IEC 60601-1-2 -
- IEC 60068-2-1/ and the following -
- IEC 10993-1 -
Clinical tests:
Introduction: Polysomnography (PSG) is considered the gold standard in the diagnosis of sleep disordered breathing (SDB). Because of costs and labor-intensity it is, however, performed last in graded diagnostic protocols that often involve respiratory pressure measurements via nasal pressure cannula as an alternative sensitive method for DSB detection. MicroMESAM, a newly developed screening device based on this method, allows automated analysis of apnoeas, hypopnoeas, flow limitations and snoring.
Aim and Methods: To validate the device, we first compared signal quality of MicroMESAM flow-time curves with those generated by a pneumotachograph. Then, in 50 patients suspected of having obstructive sleep apnoea, we compared MicroMESAMgenerated automated analysis with manually scored results of simultaneously collected PSG data.
MicroMESAM-generated flow-time curves corresponded Results: with oneumotachograph-generated curves in 95% of respiratory events, resulting in less 4±2% difference in respective area under the curves. MicroMESAM and PSG generated numbers of apnoeas (r=0.99) and hypopnoea (r=0.81), as well as AHI (r=0.98) correlated highly, displaying mean differences in AHI of 3.8, and in 1.96 intervall of +11.1 to -3.5/h. Sensitivities and specificities for SDB were 97.3%, respective 46% at SDB-defining AHI of 5, and 100%, respective 87.5%, at SDB-defining AHI of 10.
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Summary: MicroMESAM-qenerated flow-time curves correspond well well with pneumotachograph generated curves, producing automated AHls that are highly sensitive in detecting SDB. MicroMESAM, therefore, is suitable as a screening device for SDB.
Conclusion:
The MicroMESAM® Basic-Set is substantially equivalent to the predicate SECTOR Medical Corp. ApLabTM™. Both Ventilatory Effort Recorders have the same intended use. Based on verification and validation testing completed on the microMESAM® Basic-Set we conclude that the differences do not affect safety and effectiveness of the MicroMESAM® Basic-Set.
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Image /page/4/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus symbol with three wavy lines representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
JUL 01 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Map Medizintechnik Fur Arzt Und Patient GMBH C/O Mr. David D' Cruz Vice President ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K040576
Trade/Device Name: microMESAM Basic-Set Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: June 3, 2004 Received: June 7, 2004
Dear Mr. D' Cruz
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. D' Cruz
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
microMESAM® Basic-Set is used for recording the patient's respiratory nasal pressure during sleep. The device is intended for respiratory hasal p device to determine the need for clinical ase as a sereeming action by polysomnography based on the patient's test score.
| yes | |
|---|---|
| Prescription Use(Part 21 CFR 801 Subpart D) |
AND/OR
| no | |
|---|---|
| Over-The-Counter Use(21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quy Suhom
(Division Sign Off) Division of Anesthesiology, General Hos Infection Corirol, Dental Dev
510(k) Number:
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).